7PA
1971 ■
U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Public Health Service National Institutes of Health
Office for Protection from Research Risks , OD, NIH
DHEW Policy and Regulations on Protection of Human Subjects
Je arc cm' losing a ro|v »( lh« In-iti Hit jnii.it .ni.le u> PH KU' Pol icy
on Protection of Human Subjects , dated December 1, 1971. This
document became obsolete with the promulgation on March 13, 197a
of the Department of Health, Edu cation, and Welfare re gulations
on protection of human subjects. ) As a result, the Institutionary
C~ Guide must be read together with the regulation s. A copy of the /
latter is enclosed. -
Tnsi iiui imi.ll 'inidr p. i . i ;■, r . i pi i s wiiii.ii mvc undergone major changes
in codification as regulation are as follows:
POLICY (p. 1) by § 46.!
APPLICABILITY (pp. 1 and 2) by § 46.3 (b)
INSTITUTIONAL REVIEW
A. 1 (Committee requirements, p. 4) by § 46.6 (b)
A. 2 c (Informed consent, p. 7) by § 46.3 (c)
TIMING AND CERTIFICATION (p. 11) by | 46.11 and (see also para. J.
p. 18915)
DOCUMENTATION OF INFORMED CONSENT (pp. 7 and 15) by § 46.10
ENFORCEMENT (p. 17) by g 46.21
In addition § 46.3 (b) , S 46.6 (d) and S 46.7 (e) , § 46.8, S 46.15,
§ 46.17, and § 46.19 (b) represent major additions to the regulatioi
as compared with the policy.
The Institutional Guide will be revised and reissued as soon as
2 Enclosures
DHEW Publication No. (NIH) 72-102
December 1, 1971
For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402- Price 25 cents
Stock Number 1740-0326
iii
FOREWORD
The Department's basic policy, quoted in the first few paragraphs
of this Guide, is simple in concept. However, simplicity in conception
is not always easily translated into simplicity in application. Many
of the basic terms of the policy, such as subject, risk, and informed
consent, are differently understood in the several professions that
participate in the varied grant and contract programs supported by
the Department. This Guide provides working definitions of the policy's
more critical terms, and outlines flexible operating procedures which
can be adapted to a variety of grant and contract mechanisms.
A flexible policy is essential. Research, development, and the re-
duction to practice of new ideas are not carried out in a practical,
ethical, or legal vacuum. The public interest obviously would not be
served by an inflexible approach to what can or should be done.
Ultimately, the decisions required by this policy must depend upon
the common sense and sound professional judgment of reasonable
men. The Department's policy and the Guide are intended to provide
room for the exercise of this judgment.
In its present form, the Guide reflects several years' experience
with an earlier Public Health Service policy. It incorporates many
comments and suggestions by representatives of grantee and con-
tractor institutions, and by consultants and staff of the operating
agencies of the Department. Future experience in the application of
the policy in the fields of health, education, and welfare will simulta-
neously raise questions and suggest changes. Correspondence should
be addressed to the Chief, Institutional Relations Section, Division of
Research Grants, National Institutes of Health, Bethesda, Md. 20014.
D. T. Chalkley, Ph. D.
Chief, Institutional Relations Section
Division of Research Grants, NIH, DHEW
V
CONTENTS
Page
FOREWORD iii
POLICY: Grants and Contracts 1
APPLICABILITY 1
A. General 1
B. Subject — Definition 1
C. At Risk — Definition 2
D. Types of Risks and Applicability of the Policy 2
E. Established and Accepted Methods 3
F. Necessity to Meet Needs 3
INSTITUTIONAL REVIEW 4
A. Initial Review of Projects 4
1. Committee, Composition and Functions 4
2. Statement of Principles 5
3. Review Process 5
a. Rights and Welfare of Subjects: Identity of Sub-
jects, Confidentiality and Privacy, Legal Rights __ 5
b. Risk/Benefit Considerations: Benefits to Subjects —
Substantial or Negligible, Volunteers, Motivation. 6
c. Informed Consent: Basic Elements; Institutional
Liability for Negligence, Debriefing 7
B. Continuing Review 8
C. Communication of the Committee's Action, Advice, and
Counsel 9
D. Maintenance of an Active and Effective Committee 9
ASSURANCES 9
A. Negotiation of Assurances 9
B. Types of Assurances 10
1. General Assurance 10
2. Special Assurance 10
C. Minimum Requirements for General Assurances 10
1. Statement of Compliance 10
2. Implementing Guidelines 10
a. Statement of Principles 10
b. Committee Membership 10
c. Specific Procedures, Review of Proposals 10
d. Specific Procedures, Advice to and Reports from
Project Directors 11
e. Specific Procedures, Institutional Follow-up on
Committee Action 11
D. Minimum Requirements for Special Assurance 11
vi
Page
TIMING AND CERTIFICATION OF INSTITUTIONAL REVIEW 11
A. General Assurances 11
1. Timely Review 11
2. Pending Review .._ 11
3. Completion of Pending Review 12
4. Proposals Lacking Definite Plans 12
5. Proposals Submitted With No Intent of Involving
Human Subjects 1 2
B. Special Assurances 13
COOPERATIVE ACTIVITIES 13
A. Institutions With General Assurances 13
1. Institutional Review Relationships 13
a. Cooperating Institutions With Accepted General
Assurances . 13
b. Cooperating Institutions With No Accepted Gen-
eral Assurance 14
c. Interinstitutional Joint Reviews 14
B. Institutions With Special Assurances _. 14
INSTITUTIONAL ADMINISTRATION OF ASSURANCES 14
A. Institutional Responsibility 14
B. Executive Functions 15
C. Assurance Implementation 15
D. Documentation 15
1. General 15
2. Informed Consent 16
a. Written Consent 16
b. Oral Consent "Short" Form 16
c. Modification of Written or Oral Consent Forms __ 16
3. Reporting to DHEW 16
ENFORCEMENT 17
DEPARTMENTAL REVIEW OF ASSURANCES 17
ATTACHMENT
A EXAMPLE OF A STATEMENT OF COMPLIANCE (PART ONE
OF A GENERAL INSTITUTIONAL ASSURANCE) 18
B SPECIAL INSTITUTIONAL ASSURANCE IN CONNECTION
WITH SINGLE PROJECTS INVOLVING HUMAN SUBJECTS _ 19
INSTRUCTIONS FOR PREPARING SPECIAL ASSURANCE 21
C LIST OF CODES OR STATEMENTS OF PRINCIPLES 23
vii
NOTE
Bold face indicates policy as stated in DHEW Grant Administra-
tion Manual Chapter 1-40.
Light face indicates interpretation of DHEW policy.
1
POLICY
Safeguarding the rights and welfare of human subjects involved
in activities supported by grants or contracts from the Department
of Health, Education, and Welfare is the responsibility of the institu-
tion which receives or is accountable to the DHEW for the funds
awarded for the support of the activity.
In order to provide for the adequate discharge of this institutional
responsibility, it is the policy of the Department that no grant or
contract for an activity involving human subjects shall be made unless
the application for such support has been reviewed and approved
by an appropriate institutional committee.
This review shall determine that the rights and welfare of the
subjects involved are adequately protected, that the risks to an indi-
vidual are outweighed by the potential benefits to him or by the
importance of the knowledge to be gained, and that informed con-
sent is to be obtained by methods that are adequate and appropriate.
En addition the committee must establish a basis for continuing
review of the activity in keeping with these determinations.
The institution must submit to the DHEW, for its review, approval,
and official acceptance, an assurance of its compliance with this
policy. The institution must also provide with each proposal involving
human subjects a certification that it has been or will be reviewed in
accordance with the institution's assurance.
No grant or contract involving human subjects at risk will be made
to an individual unless he is affiliated with or sponsored by an insti-
tution which can and does assume responsibility for the protection
of the subjects involved.
Since the welfare of subjects is a matter of concern to the Depart-
ment of Health, Education, and Welfare as well as to the institution,
no grant or contract involving human subjects shall be made unless
the proposal for such support has been reviewed and approved by
an appropriate professional committee within the responsible com-
ponent of the Department. As a result of this review, the committee
may recommend to the operating agency, and the operating agency
may require, the imposition of specific grant or contract terms pro-
viding for the protection of human subjects, including requirements
for informed consent.
APPLICABILITY
A. General
This policy applies to all grants and contracts which support ac-
tivities in which subjects may be at risk.
B. Subject
This term describes any individual who may be at risk as a conse-
2
quence of participation as a subject in research, development, demon-
stration, or other activities supported by DHEW funds.
This may include patients; outpatients; donors of organs, tissues, and
services; informants; and normal volunteers, including students who are
placed at risk during training in medical, psychological, sociological, educa-
tional, and other types of activities supported by DHEW.
Of particular concern are those subjects in groups with limited civil free-
dom. These include prisoners, residents or clients of institutions for the
mentally ill and mentally retarded, and persons subject to military discipline.
The unborn and the dead should be considered subjects to the extent
that they have rights which can be exercised by their next of kin or legally
authorized representatives.
C. At Risk
An individual is considered to be "at risk" if he may be exposed
to the possibility of harm — physical, psychological, sociological, or
other — as a consequence of any activity which goes beyond the
application of those established and accepted methods necessary to
meet his needs. The determination of when an individual is at risk
is a matter of the application of common sense and sound profes-
sional judgment to the circumstances of the activity in question.
Responsibility for this determination resides at all levels of institu-
tional and departmental review. Definitive determination will be made
by the operating agency.
D. Types of Risks and Applicability of the Policy
1. Certain risks are inherent in life itself, at the time and in the places
where life runs its course. This policy is not concerned with the ordinary
risks of public or private living, or those risks associated with admission
to a school or hospital. It is not concerned with the risks inherent in pro-
fessional practice as long as these do not exceed the bounds of established
and accepted procedures, including innovative practices applied in the
interest of the individual patient, student or client.
Risk and the applicability of this policy are most obvious in medical and
behavioral science research projects involving procedures that may induce
a potentially harmful altered physical state or condition. Surgical and
biopsy procedures; the removal of organs or tissues for study, reference,
transplantation, or banking; the administration of drugs or radiation; the
use of indwelling catheters or electrodes; the requirement of strenuous
physical exertion; subjection to deceit, public embarrassment, and humilia-
tion are all examples of procedures which require thorough scrutiny by both
the Department of Health, Education, and Welfare and institutional com-
mittees. In general those projects which involve risk of physical or psy-
chological injury require prior written consent.
2. There is a wide range of medical, social, and behavioral projects
and activities in which no immediate physical risk to the subject is in-
volved; e.g., those utilizing personality inventories, interviews, questionnaires,
or the use of observation, photographs, taped records, or stored data.
However, some of these procedures may involve varying degrees of dis-
comfort, harassment, invasion of privacy, or may constitute a threat to the
3
subject's dignity through the imposition of demeaning or dehumanizing
conditions.
3. There are also medical and biomedical projects concerned solely with
organs, tissues, body fluids, and other materials obtained in the course of
the routine performance of medical services such as diagnosis, treatment
and care, or at autopsy. The use of these materials obviously involves no
element of physical risk to the subject. However, their use for many research,
training, and service purposes may present psychological, sociological, or
legal risks to the subject or his authorized representatives. In these instances,
application of the policy requires review to determine that the cir-
cumstances under which the materials were procured were appropriate
and that adequate and appropriate consent was, or can be, obtained for
the use of these materials for project purposes.
4. Similarly, some studies depend upon stored data or information
which was often obtained for quite different purposes. Here, the reviews
should also determine whether the use of these materials is within the
scope of the original consent, or whether consent can be obtained.
E. Established and Accepted Methods
Some methods become established through rigorous standardization
procedures prescribed, as in the case of drugs or biologicals, by law or,
as in the case of many educational tests, through the aegis of professional
societies or nonprofit agencies. Acceptance is a matter of professional
response, and determination as to when a method passes from the experi-
mental stage and becomes "established and accepted" is a matter of
judgment.
In determining what constitutes an established and accepted method,
consideration should be given to both national and local standards of
practice. A management procedure may become temporarily established
in the routine of a local institution bu+ still fail to win acceptance at the
national level. A psychological inventory may be accepted nationally,
but still contain questions which are disturbing or offensive to a local
population. Surgical procedures which are established and accepted in
one part of the country may be considered experimental in another, not
due to inherent deficiencies, but because of the lack of proper facilities
and trained personnel. Diagnostic procedures which are routine in the
United States may pose serious hazards to an undernourished, heavily in-
fected, overseas population.
If doubt exists as to whether the procedures to be employed are estab-
lished and accepted, the activity should be subject to review and ap-
proval by the institutional committee.
F. Necessity to Meet Needs
Even if considered established and accepted, the method may place
the subject at risk if it is being employed for purposes other than to
meet the needs of the subject. Determination by an attending professional
that a particular treatment, test, regimen, or curriculum is appropriate for
a particular subject to meet his needs limits the attendant risks to those
inherent in the delivery of services, or in training.
On the other hand, arbitrary, random, or other assignment of subjects
4
to differing treatment or study groups in the interests of a DHEW sup-
ported activity, rather than in the strict interests of the subject, introduces
the possibility of exposing him to additional risk. Even comparisons of two
or more established and accepted methods may potentially involve exposure
of at least some of the subjects to additional risks. Any alteration of the
choice, scope, or timing of an otherwise established and accepted method,
primarily in the interests of a DHEW activity, also raises the issue of
additional risk.
If doubt exists as to whether the procedures are intended solely to
meet the needs of the subject, the activity should be subject to review
and approval by the institutional committee.
INSTITUTIONAL REVIEW
A. Initial Review of Projects
I. Review must be carried out by an appropriate institutional com-
mittee. The committee may be an existing one, such as a board of trustees,
medical staff committee, utilization committee, or research committee, or
it may be specially constituted for the purpose of this review. Institutions
may utilize subcommittees to represent major administrative or subordinate
components in those instances where establishment of a single committee
is impracticable or inadvisable. The institution may utilize staff, consultants,
or both.
The committee must be composed of sufficient members with varying
backgrounds to assure complete and adequate review of projects and
activities commonly conducted by the institution. The committee's mem-
bership, maturity, experience, and expertise should be such as to justify
respect for its advice and counsel. No member of an institutional committee
shall be involved in either the initial or continuing review of an activity
in which he has a professional responsibility, except to provide informa-
tion requested by the committee. In addition to possessing the professional
competence to review specific activities, the committee should be able to
determine acceptability of the proposal in terms of institutional commit-
ments and regulations, applicable law, standards of professional conduct
and practice, and community attitudes. 1 The committee may therefore
need to include persons whose primary concerns lie in these areas rather
than in the conduct of research, development, and service programs of
the types supported by the DHEW.
If an institution is so small that it cannot appoint a suitable committee
from Its own staff, it should appoint members from outside the institution.
Committee members shall be identified by name, occupation or
position, and by other pertinent indications of experience and com-
petence in areas pertinent to the areas of review such as earned
degrees, board certifications, licensures, memberships, etc.
Temporary replacement of a committee member by an alternate of
comparable experience and competence is permitted in the event a mem-
1 In the United States, the regulations of the Food and Drug Administration (21 CFR 130)
provide that the committee must possess competencies to determine acceptability of the
project in these terms in order to review proposals for investigational new drug (IND)
studies.
5
ber is momentarily unable to fulfill committee responsibility. The DHEW
should be notified of any permanent replacement or additions.
2. The institution should adopt a statement of principles that will
assist it in the discharge of its responsibilities for protecting the rights
and welfare of subjects. This may be an appropriate existing code
or declaration or one formulated by the institution itself. 2 It is to be
understood that no such principles supersede DHEW policy or appli-
cable law.
3. Review begins with the identification of those projects or activities
which involve subjects who may be at risk. In institutions with large grant
and contract programs, administrative staff may be delegated the responsi-
bility of separating those projects which do not involve human subjects
in any degree; i.e., animal and nonhuman materials studies. However, deter-
minations as to whether any project or activity involves human subjects
at risk is a professional responsibility to be discharged through review by
the committee, or by subcommittees.
If review determines that the procedures to be applied are to be limited
to those considered by the committee to be established, accepted, and
necessary to the needs of the subject, review need go no further; and the
application should be certified as approved by the committee. Such proj-
ects involve human subjects, but these subjects are not considered to be
at risk.
If review determines that the procedures to be applied will place the
subject at risk, review should be expanded to include the issues of the
protection of the subject's rights and welfare, of the relative weight of
risks and benefits, and of the provision of adequate and appropriate con-
sent procedures.
Where required by workload considerations or by geographic separa-
tion of operating units, subcommittees or mail review may be utilized to
provide preliminary review of applications.
Final review of projects involving subjects at risk should be carried out
by a quorum of the committee. 3 Such review should determine, through
review of reports by subcommittees, or through its own examination of
applications or of protocols, or through interviews with those individuals
who will have professional responsibility for the proposal project or activity,
or through other acceptable procedures thaT the requirements of the
institutional assurance and of DHEW policy have been met, specifically
that:
a. The rights and welfare of the subjects are adequately protected.
Institutional committees should carefully examine applications,
protocols, or descriptions of work to arrive at an independent deter-
mination of possible risks. The committee must be alert to the possi-
bility that investigators, program directors, or contractors may, quite
unintentionally, introduce unnecessary or unacceptable hazards, or
fail to provide adequate safeguards. This possibility is particularly
true if the project crosses disciplinary lines, involves new and untried
procedures, or involves established and accepted procedures which
are new to the personnel applying them. Committees must also assure
2 Some of the existing codes or statements of principles concerned with the protection of
human subjects in research, investigation, and care are listed in attachment C.
3 In the United States, the quorum reviewing investigational new drug studies must satisfy
requirements of the Food and Drug Administration (21 CFR 130).
6
themselves that proper precautions will be taken to deal with emer-
gencies that may develop even in the course of seemingly routine
activities.
When appropriate, provision should be made for safeguarding informa-
tion that could be traced to, or identified with, subjects. The committee
may require the project or activity director to take steps to insure the
confidentiality and security of data, particularly if it may not always remain
under his direct control.
Safeguards include, initially, the careful design of questionnaires, in-
ventories, interview schedules, and other data gathering instruments and
procedures to limit the personal information to be acquired to that
absolutely essential to the project or activity. Additional safeguards include
the encoding or enciphering of names, addresses, serial numbers, and of
data transferred to tapes, discs, and printouts. Secure, locked spaces and
cabinets may be necessary for handling and storing documents and
files. Codes and ciphers should always be kept in secure places, distinctly
separate from encoded and enciphered data. The shipment, delivery, and
transfer of all data, printouts, and files between offices and institutions
may require careful controls. Computer to computer transmission of data
may be restricted or forbidden.
Provision should also be made for the destruction of all edited, obsolete
or depleted data on punched cards, tapes, discs, and other records. The
committee may also determine a future date for destruction of all stored
primary data pertaining to a project or activity.
Particularly relevant to the decision of the committees are those rights
of the subject that are defined by law. The committee should familiarize
itself through consultation with legal counsel with these statutes and com-
mon law precedents which may bear on its decisions. The provisions of
this policy may not be construed in any manner or sense that would
abrogate, supersede, or moderate more restrictive applicable law or pre-
cedential legal decisions.
Laws may define what constitutes consent and who may give consent,
prescribe or proscribe the performance of certain medical and surgical
procedures, protect confidential communications, define negligence, define
invasion of privacy, require disclosure of records pursuant to legal process,
and limit charitable and governmental immunity (see, e.g., the University
of Pittsburgh Law Manual).
b. The risks to an individual are outweighed by the potential
benefits to him or by the importance of the knowledge to be gained.
The committee should carefully weigh the known or foreseeable risks
to be encountered by subjects, the probable benefits that may accrue to
them, and the probable benefits to humanity that may result from the
subject's participation in the project or activity. If it seems probable
that participation will confer substantial benefits on the subjects, the com-
mittee may be justified in permitting them to accept commensurate or
lesser risks. If the potential benefits are insubstantial, or are outweighed by
risks, the committee may be justified in permitting the subjects to accept
these risks in the interests of humanity. The committee should consider the
possibility that subjects, or those authorized to represent subjects, may
be motivated to accept risks for unsuitable or inadequate reasons. In such
instances the consent procedures adopted should incorporate adequate
safeguards.
7
Compensation to volunteers should never be such as to constitute an
undue inducement.
No subject can be expected to understand the issues of risks and
benefits as fully as the committee. Its agreeme.nl- that consent can reason-
ably be sought for subject participation in a project or activity is of
paramount practical importance.
"The informed consent of the subject, while often a legal necessity is a
goal toward which we must strive, but hardly ever achieve except in the
simplest cases."
(Henry K. Beecher, M.D.)
c. The informed consent of subjects will be obtained by methods
that are adequate and appropriate.
Note. — In the United States, adherence to the regulations of the Food and Drug Adminis-
tration (21 CFR 130) governing consent in projects involving investigational new drugs
(IND) is required by law.
Informed consent is the agreement obtained from a subject, or from
his authorized representative, to the subject's participation in an
activity.
The basic elements of informed consent are:
1. A fair explanation of the procedures to be followed, includ-
ing an identification of those which are experimental;
2. A description of the attendant discomforts and risks;
3. A description of the benefits to be expected;
4. A disclosure of appropriate alternative procedures that would
be advantageous for the subject;
5. An offer to answer any inquiries concerning the procedures;
6. An instruction that the subject is free to withdraw his consent
and to discontinue participation in the project or activity at
any time.
In addition, the agreement, written or oral, entered into by the
subject, should include no exculpatory language through which the
subject is made to waive, or to appear to waive, any of his legal
rights, or to release the institution or its agents from liability for
negligence. 4
Informed consent must be documented (see Documentation, p. 35).
Consent should be obtained, whenever practicable, from the subjects
themselves. When the subject group will include individuals who are not
legally or physically capable of giving informed consent, because of age,
mental incapacity, or inability to communicate, the review committee
should consider the validity of consent by next of kin, legal guardians, or
by other qualified third parties representative of the subjects' interests.
In such instances, careful consideration should be given by the committee
not only to whether these third parties can be presumed to have the
necessary depth of interest and concern with the subjects' rights and
welfare, but also to whether these third parties will be legally authorized
to expose the subjects to the risks involved.
4 Use of exculpatory clauses in consent documents is considered contrary to public policy.
Tunkl vs. Regents of University of California, 60 Cal. 2d 92, 32 Cat. Rptr.33, 383 P. 2d
441 (1963), Annot., 6 A.L.R. 3d 693 (1966).
8
The review committee will determine if the consent required, whether
to be secured before the fact, in writing or orally, or after the fact follow-
ing debriefing, or whether implicit in voluntary participation in an ade-
quately advertised activity, is appropriate in the light of the risks to
the subject, and the circumstances of the project.
The review committee will also determine if the information to be given
to the subject, or to qualified third parties, in writing or orally, is a fair
explanation of the project or activity, of its possible benefits, and of its
attendant hazards.
Where an activity involves therapy, diagnosis, or management, and a
professional/patient relationship exists, it is necessary "to recognize that
each patient's mental and emotional condition is important . . . and that
in discussing the element of risk, a certain amount of discretion must be
employed consistent with full disclosure of fact necessary to any informed
consent." 5
Where an activity does not involve therapy, diagnosis, or management,
and a professional/subject rather than a professional/patient relationship
exists, "the subject is entitled to a full and frank disclosure of all the facts,
probabilities, and opinions which a reasonable man might be expected to
consider before giving his consent." 6
When debriefiing procedures are considered as a necessary part of the
plan, the committee should ascertain that these will be complete and
prompt.
B. Continuing Review
This is an essential part of the review process. While procedures for
continuing review of ongoing projects and activities should be based in
principle on the initial review criteria, they should also be adapted to the
size and administrative structure of the institution. Institutions which are
small and compact and in which the committee members are in day-to-day
contact with professional staff may be able to function effectively with some
informality. Institutions which have placed responsibility for review in boards
of trustees, utilization committees, and similar groups that meet on frequent
schedules may find it possible to have projects re-reviewed during these
meetings.
In larger institutions with more complex administrative structures and
specially appointed committees, these committees may adopt a variety
of continuing review mechanisms. They may involve systematic review of
projects at fixed intervals, or at intervals set by the committee com-
mensurate with the project's risk. Thus, a project involving an untried
procedure may initially require reconsideration as each subject completes
his involvement. A highly routine project may need no more than annual
review. Routine diagnostic service procedures, such as biopsy and autopsy,
which contribute to research and demonstration activities generally require
no more than annual review. Spot checks may be used to supplement sched-
uled reviews.
Actual review may involve interviews with the responsible staff, or
5 Sa/go vs. leland Stanford Jr. University Board of Trustees (154 C.A. 2nd 560; 317 P.
2d 1701).
'Halushka vs. University of Saskatchewan, (1965) 53 D.L.R. (2d).
9
review of written reports and supporting documents and forms. In any
event, such review must be completed at least annually to permit certi-
fications of review on noncompeting continuation applications.
C. Communication of the Committee's Action, Advice, and
Counsel
If the committee's overall recommendation is favorable, it may simultane-
ously prescribe restrictions or conditions under which the activity may be
conducted, define substantial changes in the research plans which should be
brought to its attention, and determine the nature and frequency of interim
review procedures to insure continued acceptable conduct of the research.
Favorable recommendations by an institutional committee are, of
course, always subject to further appropriate review and rejection
by institution officials.
Unfavorable recommendations, restrictions, or conditions cannot be
removed except by the committee or by the action of another appro-
priate review group described in the assurance filed with the Depart-
ment of Health, Education, and Welfare.
Staff with supervisory responsibility for investigators and program direc-
tors whose projects or activities have been disapproved or restricted, and
institutional administrative and financial officers should be informed of the
committee's recommendations. Responsible professional staff should be in-
formed of the reasons for any adverse actions taken by the institutional
committee.
The committee should be prepared at all times to provide advice and
counsel to staff developing new projects or activities or contemplating re-
vision of ongoing projects or disapproved proposals.
D. Maintenance of an Active and Effective Committee
Institutions should establish policy determining overall committee com-
position, including provisions for rotation of memberships and appointment
of chairmen. Channels of responsibility should be established for im-
plementation of committee recommendations as they may affect the actions
of responsible professional staff, grants and contracts officers, business
officers, and other responsible staff. Provisions should be made for remedial
action in the event of disregard of committee recommendations.
ASSURANCES
A. Negotiation of Assurances
An institution applying to the DHEW for a grant or contract involv-
ing human subjects must provide written assurance that it will abide
by DHEW policy. The assurance shall embody a statement of com-
pliance with DHEW requirements for initial and continuing committee
review of the supported activities; a set of implementing guidelines,
including identification of the committee, and a description of its
review procedures or, in the case of special assurances concerned
with single projects or activities, a report of initial findings and pro-
10
posed continuing review procedures. Institutions that have not previ-
ously filed assurances should request instructions for the preparation
of an assurance from the Division of Research Grants, National
Institutes of Health.
Negotiation of assurances is the responsibility of the DRG, NIH.
Negotiation will be initiated on receipt of a copy of a grant applica-
tion, a contract proposal, or other documentation identifying the
project and the offeror or sponsoring institution.
Assurances will not be accepted from institutions or institutional
components which do not have control over the expenditure of DHEW
grant or contract funds unless they are an active part of a cooperative
project or activity.
An assurance will be accepted only after review and approval by
the DRG, NIH.
B. Types of Assurance
Assurances may be one of two types:
1. Genera/ assurance. — A general assurance describes the review
and implementation procedures applicable to all DHEW-supported
activities within an institution, regardless of the number, location, or
types of its components (see attachment A). General assurances will
be required from institutions having a significant number of concurrent
DHEW projects or activities involving human subjects.
2. Spec/a/ assurance. — A special assurance will, as a rule, describe
those review and implementation procedures applicable to a single
project or activity (see attachment B). Special assurances may also
be approved in modified forms to meet unusual requirements either
of the operating agency or of the institution receiving a grant or
contract. Special assurances are not to be solicited from institutions
which have accepted general assurances on file.
C. Minimum Requirements for General Assurances
1. Statement of compliance. — A formal statement of compliance
with DHEW policy must be executed by an appropriate institutional
official.
2. Implementing guidelines. — The institution must include as part
of its assurance implementing guidelines that specifically provide for:
a. The statement of principles that will assist the institution in the
discharge of its responsibilities for protecting the rights and welfare
of subjects. This may be an appropriate existing code or declaration
or one formulated by the institution itself.
b. A committee or committee structure which will conduct initial
and continuing reviews. Committee members shall be identified by
name, occupation or position, and by other pertinent indications of
experience and competence in areas pertinent to the areas of review
such as earned degrees, board certifications, licensures, memberships,
etc.
c. The procedures which the institution will follow in carrying out
its initial and continuing review of proposals and activities to insure
that:
11
(1) The rights and welfare of subjects are adequately protected;
(2) The risks to subjects are outweighed by potential benefits;
(3) The informed consent of subjects will be obtained by methods
that are adequate and appropriate.
d. The procedures which the committee will follow to provide ad-
vice and counsel to project and program directors with regard to the
committee's actions as well as the requirement for reporting to the
committee any emergent problems or proposed procedural changes.
e. The procedures which the institution will follow to maintain
an active and effective committee and to implement its recommenda-
tions.
D. Minimum Requirements for Special Assurance
An acceptable special assurance covering a single activity consists
of a properly completed statement of compliance, similar to that
illustrated by attachment B. This assurance shall identify the specific
grant or contract involved by its number, if known; by its full title;
and by the name of the project or program director, principal investi-
gator, fellow, or other person immediately responsible for the con-
duct of the activity. The assurance shall be signed by a committee
of not fewer than three members and executed by an appropriate
institutional official. The committee shall describe in general terms
those risks to the subject that it recognizes as inherent in the activity.
Consent procedures to be used are to be described. Any consent
statement to be signed, heard, or read by the subject or responsible
third parties should be attached. The assurance should outline the
circumstances under which the director or investigator will be required
to inform the committee of proposed changes in the activity, or of
emergent problems involving human subjects. The assurance should
also indicate whether the director or investigator will be required
to submit written reports, appear for interview, or be visited by the
committee or committees to provide for continuing review. It should
also indicate the intervals at which such reviews will take place.
TIMING AND CERTIFICATION OF INSTITUTIONAL REVIEW
A. General Assurances
1. Timely review. — All proposals involving human subjects submit-
ted by institutions with accepted general assurances should, whenever
possible, be given institutional review and approval prior to submis-
sion to the DHEW. The proposal or application should be appropriately
marked in the spaces provided on forms, or the following statement
should be typed on the lower or right hand margin of the page
bearing the name of the institutional official authorized to sign or
execute applications or proposals for the institution:
"HUMAN SUBJECTS— REVIEWED AND APPROVED ON (date) "
(This date should be no more than 90 days prior to the submission
date, and must not be more than 12 months prior to the proposed
starting date.)
2. Pending review. — If it will be necessary to delay the review, the
12
proposal is to be appropriately marked in the spaces provided on
forms, or the following statement is to be typed in the lower or right
hand margin of the page bearing the name of the institutional official
authorized to sign or execute applications or proposals for the insti-
tution:
"HUMAN SUBJECTS— REVIEW PENDING ON (date) "
(This date should be at least one month earlier than the proposed
starting date of the project to avoid possible conflict with the award
date.)
3. Completion of pending review. — Review should be initiated as
soon as possible after the submission of the proposal so that final
action can be completed prior to the pending review date. If this
final action is disapproval, or is approval contingent on substantive
changes in the proposal, the operating agency is to be notified
promptly by telegram; an immediate confirmatory letter; and, where
appropriate, by withdrawal of the application from further considera-
tion by the agency.
4. Institutional review of proposals lacking definite plans or spe-
cifications for the involvement of human subjects. — Certain types of
proposals are submitted with the knowledge that human subjects
are to be involved within the project period, but definite plans for
this involvement cannot properly be included in the proposal. These
include (1) certain training grants where trainee projects remain to
be selected, and (2) research, pilot, or developmental studies in which
involvement depends upon such things as the completion of instru-
ments, or of prior animal studies, or upon the purification of com-
pounds.
Such proposals should be reviewed and certified in the same man-
ner as more complete proposals. The initial certification indicates
institutional approval of the applications as submitted, and commits
the institution to later review of the plans when completed. Such
later review should be completed prior to the beginning of the budget
period during which actual involvement of human subjects is to begin.
5. Institutional review of proposals not submitted with the intent
of involving human subjects. — If a proposal, at the time it is sub-
mitted to the DHEW, does not anticipate involving or intend to involve
human subjects, no certification should be submitted. In those in-
stances, however, where funds are awarded in response to the pro-
posal and it later becomes appropriate to use all or parts of these
funds for activities which will involve human subjects, such use
must be reviewed and approved in accordance with the institutional
assurance prior to the use of subjects:
a. Where support is provided by project grants or contracts, review
and approval of such changes must be certified to the awarding
agency or contracting agency, together with a description of the
proposed change in the project plan or contract workscope. Subjects
should not be used prior to receipt of approval from agency staff or
from the project officer concerned.
b. Where support is provided by a mandatory grant or institutional
grant, in which cases the institution determines within broad guide-
lines the project or activities supported, including the use of human
13
subjects (i.e., general research support grants, clinical research center
projects), review must be carried out in accordance with the institu-
tional assurance. Certification for individual projects need not be
forwarded to the awarding agency.
Whenever the committee is uncertain as to whether a change
should or should not be reported, the question should be referred
to the operating agency concerned.
All certifications are subject to verfication by DHEW representatives
authorized to examine institutional and committee records.
B. Special Assurances
When a special assurance is submitted, it provides certification
for the initial grant or contract period concerned. No additional docu-
mentation is required. If the terms of the grant or contract provide
for additional years of support, with annual obligation or funds,
the noncompeting renewal application or proposal shall be certified
in the manner described in the preceding section.
COOPERATIVE ACTIVITIES
Cooperative activities are those which involve other than the
grantee or prime contractor (such as a contractor under a grantee or
a subcontractor under a prime contractor). In such instances the
grantee or prime contractor may obtain access to all or some of the
human subjects involved through the cooperating institution. Regard-
less of the distances involved and the nature of the cooperative
arrangement, the basic DHEW policy applies and the grantee or prime
contractor remains responsible for safeguarding the rights and wel-
fare of the subjects. The manner in which this responsibility can be
discharged depends on whether the grantee or contractor holds an
institutional general assurance or an institutional special assurance.
A. Institutions with General Assurances
1. Initial and continuing institutional review may be carried out by
one or a combination of procedures:
— By the grantee's or contractor's committee;
— By the committee reviews conducted at both institutions; or
— Through cooperation of appropriate individuals or committees
representing the cooperating institution.
The procedures to be followed must be made a matter of record in
the institutional files for the grant or contract before funds are re-
leased by the grantee or contractor for the cooperative project. There
are three relationships that may govern in reference to the cooperating
institution:
a. Cooperating institutions with accepted general assurances
When the cooperating institution has on file with the DHEW an ac-
cepted general assurance, the grantee or contractor may request the
cooperator to conduct its own independent review and to report to
the grantee's or contractor's committee the cooperating committee's
recommendations on those aspects of the activity that concern indi-
14
viduals for whom the cooperating institution has responsibility in
accordance with its own assurance. The grantee or contractor may,
at its discretion, concur with or further restrict the recommendations
of the cooperating institution. It is the responsibility of the grantee or
contractor to maintain communication with the cooperating institu-
tional committees. The cooperating institution should promptly notify
the grantee or contracting institution whenever the cooperating insti-
tution finds the conduct of the project or activity within its purview
unsatisfactory.
b. Cooperating institution with no accepted general assurance
When the cooperating institution does not have an accepted assurance
on file with the DHEW, the awarding agency concerned may request
the DRG, NIH, to negotiate an assurance.
c. Interinstitutional joint reviews. — The grantee or contracting insti-
tution may wish to develop an agreement with cooperating institutions
to provide for a review committee with representatives from coop-
erating institutions. Representatives of cooperating institutions may
be appointed as ad hoc members of the grantee or contracting insti-
tution's existing review committee or, if cooperation is on a frequent
or continuing basis as between a medical school and a group of
affiliated hospitals, appointments may be made permanent. Under
some circumstances component subcommittees may be established
within cooperating institutions. All such cooperative arrangements
must be accepted by the Department as part of a general assurance,
ar as an amendment to a general assurance, or in unusual situations
as determined by the DRG, NIH, as a special assurance.
B. Institutions with Special Assurances
While responsibility for initial and continuing review necessarily
lies with the contractor, the DHEW will also require acceptable assur-
ances from those cooperating institutions having immediate responsi-
bility for subjects.
If the cooperating institution has on file with the DHEW an ac-
cepted general assurance, the contractor shall request the cooperator
to conduct its own independent review of those aspects of the
project or activity which will involve human subjects for which it has
immediate responsibility. Such a request shall be in writing and should
provide for direct notification of the contractor's committee in the
event that the cooperator's committee finds the conduct of the activity
unsatisfactory.
If the cooperating institution does not have an accepted general
assurance on file with the DHEW, the operating agency concerned
must request the DRG, NIH, to negotiate an assurance.
INSTITUTIONAL ADMINISTRATION OF ASSURANCES
A. Institutional Responsibility
The grantee or contracting institution's administration is accountable
to the Department for effectively carrying out the provisions of the
institutional assurance for the protection of human subjects as ac-
15
cepted and recognized by the Department. Revisions in the institu-
tional assurance, including the implementing procedures, are to be
reported to the Department prior to the date such revisions become
effective. Revision without prior notification may result in withdrawal
of departmental recognition of the institution's assurance.
B. Executive Functions
Specific executive functions to be conducted by the institutional
administration include institutional policy formulation, development,
promulgation, and continuing indoctrination of personnel. Appropriate
administrative assistance and support must be provided for the com-
mittee's functions. Implementation of the committee's recommenda-
tions through appropriate administrative action and followup is a
condition of acceptance of an assurance. Committee approvals and
recommendations are, of course, subject to review and to disapproval
or further restriction by institutional officials. Committee disapprovals,
restrictions, or conditions cannot be rescinded or removed except
by action of the committee or another appropriate review group as
described and accepted in the assurance filed with the Department.
C. Assurance Implementation
Under no circumstances shall proposed activity plans, not approved
by the committee, be implemented with Department funds. The prin-
cipal investigator, program or project director, or other responsible
staff must be notified as promptly as possible of committee actions,
including any restrictive recommendations made by the institutional
committee or the administration. They must also be informed and
reminded of their continuing responsibility to bring to the attention
of the committee any proposed significant changes in project or
activity plans or any emergent problems that will affect human
subjects. Where continuing review of projects involves the channels
of administrative authority in the institution, notification of committee
actions should be sent through these channels. Establishment of
mechanisms for consultation and appeal by investigators and subjects
may be an important condition of acceptance of an assurance by the
Department.
D. Documentation
1. General. — Development of appropriate documentation and re-
porting procedures is an essential administrative function. The files
must include copies of all documents presented or required for initial
and continuing review by the institutional review committee and
transmittals on actions, instructions, and conditions resulting from
review committee deliberations addressed to the activity director
are to be made part of the official institutional files for the supported
activity. Committee meeting minutes including records of discussions
of substantive issues and their resolution are to be retained by the
institution and be made available upon request to representatives
of the DHEW.
16
2. Informed consent. — An institution proposing to place any indi-
vidual at risk is obligated to obtain and document his informed
consent; the terms "at risk" and "informed consent" will apply as
defined previously.
The actual procedure in obtaining informed consent and the basis
for committee determinations that the procedures are adequate and
appropriate are to be fully documented. The documentation will fol-
low one of the following three forms:
a. Provision of a written consent document embodying all of the
basic elements of informed consent. This form is to be signed by the
subject or his authorized representative. A sample of the form as
approved by the committee is to be retained in its records. Completed
forms are to be handled in accordance with institutional practice.
b. Provision of a "short" form written consent document indicating
that the basic elements of informed consent have been presented
orally to the subject. Written summaries of what is to be said to the
patient are to be approved by the committee. The "short" form is to
be signed by the subject or his authorized representative and an
auditor-witness to the oral presentation and to the subject's or his
authorized representative's signature. A copy of the approved sum-
mary, annotated to show any additions, is to be signed by the persons
obtaining the consent on behalf of the institution and by the auditor-
witness. Sample copies of the consent form and of the summaries
as approved by the committee are to be retained in its records.
Completed forms are to be handled in accordance with institutional
practice.
c. Modification of either of the above two primary procedures.
AH such modifications must be approved by the committee in the
minutes signed by the committee chairman. Granting of permission
to use modified procedures imposes additional responsibility upon
the review committee and the institution to establish that the risk to
any subject is minimum, that use of either of the primary procedures
for obtaining informed consent would surely invalidate objectives
of considerable immediate importance, and that any reasonable alter-
native means for attaining these objectives would be less advanta-
geous to the subject.
The committee's reasons for permitting modification or elimination
of any of the six basic elements of informed consent, or for altering
requirements for a subject's signature, or for signature of an auditor-
witness, or for substitution (i.e., debriefing), or other modification of
full, complete, written prior consent, must be individually and spe-
cifically documented in the minutes and in reports of committee actions
to the institutional files. Approval of any such modifications should
be regularly reconsidered as a function of continuing review and as
required for annual review, with documentation of reaffirmation, re-
vision, or discontinuation as appropriate.
3. Reporting to DHEW. — No routine reports to DHEW are required.
Significant changes in policy, procedure, or committee structure shall,
however, be promptly reported to the DRG, NIH, for review and ac-
ceptance. Review of these changes or of institutional and other
records of performance under the terms and conditions of DHEW
17
policy, may require renegotiation of the assurance or such other action
as may be appropriate.
ENFORCEMENT
The DRG, NIH, will follow up reports by reviewers, evaluators, con-
sultants, and staff of the DHEW indicating concern for the welfare
of subjects involved in approved and funded grants or contracts, and
of subjects potentially involved in activities approved but not funded,
and in disapproved proposals. On the basis of these reports and
of other sources of information, the DRG, NIH, may, in collaboration
with the operating agency concerned, correspond with or visit insti-
tutions to discuss correction of any apparent deficiencies in its imple-
mentation of the procedures described in its institutional assurance.
If, in the judgment of the Secretary, an institution has failed in a
material manner to comply with the terms of this policy with respect
to a particular DHEW grant or contract, he may require that it be
terminated in the manner provided for in applicable grant or procure-
ment regulations. The institution shall be promptly notified of such
finding and of the reason therefor.
If, in the judgment of the Secretary, an institution fails to discharge
its responsibilities for the protection of the rights and welfare of the
individuals in its care, whether or not DHEW funds are involved,
he may question whether the institution and the individuals con-
cerned should remain eligible to receive future DHEW funds for
activities involving human subjects. The institution and individuals
concerned shall be promptly notified of this finding and of the reasons
therefor.
DEPARTMENTAL REVIEW OF ASSURANCES
All assurances submitted for approval are to be forwarded to the
DRG, NIH, for review and acceptance on behalf of the Department.
Review will be principally concerned with the adequacy of the pro-
posed committee in the light of the probable scope of the applicant
institution's activities, and with the appropriateness of the proposed
initial and continuing review in the light of the probable risks to be
encountered, the types of subject populations involved, and the size
and complexity of the institution's administration. Institutions sub-
mitting inadequate assurances will be informed of deficiencies. The
appropriate operating agency will be kept informed, on request, of
the status and acceptance of an assurance.
18
ATTACHMENT A
EXAMPLE OF A STATEMENT OF COMPLIANCE
PART ONE OF A GENERAL INSTITUTIONAL ASSURANCE
The (name of institution) will comply with the policy for the pro-
tection of human subjects participating in activities supported directly
or indirectly by grants or contracts from the Department of Health,
Education, and Welfare. In fulfillment of its assurance:
This institution will establish and maintain a committee competent
to review projects and activities that involve human subjects. The
committee will be assigned responsibility to determine for each ac-
tivity as planned and conducted that:
The rights and welfare of subjects are adequately protected.
The risks to subjects are outweighed by potential benefits.
The informed consent of subjects will be obtained by methods
that are adequate and appropriate.
This institution will provide for committee reviews to be conducted
with objectivity and in a manner to ensure the exercise of inde-
pendent judgment of the members. Members will be excluded from
reviews of projects or activities in which they have an active role
or a conflict of interests.
This institution will encourage continuing constructive communica-
tion between the committee and the project directors as a means of
safeguarding the rights and welfare of subjects.
This institution will provide for the facilities and professional atten-
tion required for subjects who may suffer physical, psychological, or
other injury as a result of participation in an activity.
This institution will maintain appropriate and informative records
of committee reviews of applications and active projects, of docu-
mentation of informed consent, and of other documentation that may
pertain to the selection, participation, and protection of subjects and
to reviews of circumstances that adversely affect the rights or welfare
of individual subjects.
This institution will periodically reassure itself through appropriate
administrative overview that the practices and procedures designed
for the protection of the rights and welfare of subjects are being
effectively applied and are consistent with its assurance as accepted
by the Department of Health, Education, and Welfare.
Official signing for the Institution
Signature
Title
Date
Enclosure: Implementing Guidelines, Part Two of a General Insti-
tutional Assurance.
19
ATTACHMENT B
EXAMPLE OF A STATEMENT OF COMPLIANCE
SPECIAL INSTITUTIONAL ASSURANCE IN CONNECTION WITH
SINGLE PROJECTS INVOLVING HUMAN SUBJECTS
(0) The (name of institution) will comply with the policy for the
protection of human subjects participating in projects or activities
supported by grants and contracts made by the Department of
Health, Education, and Welfare. This policy requires a review
independent of the investigator or director to safeguard the rights
and welfare of those subjects. An initial review of the application
for a grant or contract identified as sub-
mitted by this institution on behalf of
indicates that:
(1) In the opinion of this committee the risks to the rights and welfare
of the subject in this project or activity are:
The committee states that adequate safeguards against these
risks have been provided.
(2) In the opinion of the committee the potential benefits of this ac-
tivity to the subjects outweigh any probable risks. This opinion is
justified by the following reasons:
(3) In the opinion of the committee the following informed consent
procedures will be adequate and appropriate. Documentation is
attached.
(4) The committee agrees to arrange for a continuing exchange of
information and advice between itself and the investigator or
director, particularly to deal with proposed changes in project or
activity design, or with emergent problems which may alter the
investigational situation with regard to the criteria cited above.
This exchange will be implemented through:
This institution will provide whatever professional attention or facilities
are required to safeguard the rights and welfare of human subjects.
(5) The signatures, names, and occupations or titles of the members of the
committee are listed below.
Signature
Name
Occupation
or
Title
Signature
Name
Occupation
or
Title
Signature
Name
Occupation
or
Title
Signature
Name
Occupation
or
Title
Date of Committee Approval
(Continued page 20)
20
(6) Official signing for Institution
Signature
Name
Title
Address
I nstitution
Telephone Number
Date
(see instructions)
21
ATTACHMENT B
INSTRUCTIONS
An acceptable special institutional assurance consists of a properly com-
pleted formal statement of compliance with Department of Health, Educa-
tion, and Welfare policy (see attachment B), signed by a committee of
not less than three members and by an official authorized to sign for the
institution. The explanatory paragraphs which follow refer to the corre-
sponding section of the attachment.
(0) This should identify the application for a grant, contract, or award by
its identifying number, where known, or by its full title. The name should
be that of the investigator, program director, fellow, or other individual
immediately responsible for the conduct of the work.
(1) The committee should identify in general terms those risks that it recog-
nizes as probable occurrences; i.e., "Aggravation of anxiety status
through contact with interviewers," "Preservation of confidentiality of
data," "Renal injury subsequent to multiple biopsy," "Possibility of side
reactions to drugs," "Possible local hematosis and nerve injury associated
with venipuncture."
(2) The committee should identify the benefits to the subject or to mankind
in general that will accrue through the subject's participation in the
project. This should be followed by a brief discussion, weighing the risks
against the benefits.
(3) Consent procedures should be described and the minimum statement to
be used should be attached. "Students responding to the attached ad-
vertisement will be interviewed." "The project outline will be submitted
to the executive council of the PTA." "Individual teachers will be asked
to allow an observer in the rooms chosen." "Superintendents of several
State mental hospitals will be approached. The attached statement to
the next of kin or guardian will be signed by the principal investigator
and the superintendent." "The following special consent form will be
signed by each subject and his or her spouse or next of kin before
acceptance of the subject." "No prior consent will be sought. The fol-
lowing debriefing schedule will be followed within 30 minutes after com-
pletion of the test."
(4) This should indicate whether the investigator or director will be required
to submit written reports, or to appear for interviews, or will be visited
by the committee or committee representatives, and at approximately
what intervals these steps will be carried out.
(5) No further explanation is necessary. (The committee must be composed
of sufficient members with varying backgrounds to assure complete and
adequate review of the project. The committee may be an existing one,
or one especially appointed for the purpose. The institution may utilize
staff, consultants, or both. The membership should possess not only
broad competence to comprehend the nature of the project, but also
other competencies necessary in the judgments as to acceptability of the
project or activity in terms of institutional regulations, relevant law,
standards of professional practice, and community acceptance. The com-
22
mittee's maturity and experience should be such as to justify respect for
its advice and counsel.)
(No individual involved in the conduct of the project shall participate
in its review, except to provide information to the committee.)
(Committee members should be identified in the assurance by name,
positions, earned degrees, board certifications, licensures, memberships,
and other indications of experience, competence, and interest.)
The completed assurance should be attached to the application, or returned
directly to the office requesting its submission.
23
ATTACHMENT C
Codes or statements of principles which are concerned with the protection of human
ibjects in research, investigation, and care have been issued by:
Organization
World Medical Association
10 Columbus Circle
New York. N.Y. 10019
(code available from
AMA; see address listed
herein )
Code; adoption date
The Declaration of Hel-
sinki; Recommendations
Guiding Doctors in Clini-
cal Research; 1964
ReU
J.A.M.A., 197(1 I ):32, Sept.
12, 1966
Nuernberg Military Tri
bunals: U.S. v. Kar
Brandt
Text from which
"Nuernberg Code'
derived.
the Trials of War Criminals
is Before the Nuernberg
Military Tribunals, vol.
II, pp. 181-82; GPO
1949
American Medical Associa-
tion
535 North Dearborn Street
Chicago, III. 60610
(British) Medical Research
Council
20 Park Crescent
London W.I, England
AMA
for
tion;
Ethical Guidelines
Clinical Investiga-
Nov. 30, 1966
Responsibility in Investiga-
tions on Human Sub-
jects; 1964
Report of the Medical Re-
search Council for 1 962—
1963, (Cmnd. 2382), pp.
21-25
(Canadian) Medical Re-
search Council
Montreal Road
Ottawa 7, Ontario, Canada
Medical Research Council;
Extramural Programme;
1966
American Association o
Mental Deficiency
20 North Street
Willimantic, Conn. 06226
Statement on the Use of
Human Subjects for Re-
search; May 1969
American Journal of
Mental Deficiency, 74
(I):I57, July 1969
American Nurses' Associa-
tion
10 Columbus Circle
New York, N.Y. 10019
The Nurse in Research;
ANA Guidelines on Ethi-
cal Values; January 1968
American Personnel and
Guidance Association
1607 New Hampshire Ave-
nue, N.W.
Washington, D.C. 20009
American Psychological As-
sociation, Inc.
1200 17th Street, N.W.
Washington, D.C. 20036
International League of
Societies for the Men-
tally Handicapped
12 Rue Forestiere
Brussels 5, Belgium
American Personnel an,d
Guidance Association;
Code of Ethical Stand-
ards; no date specified
Ethical Standards of Psy-
chologists; Copyrighted
January 1963
Declaration of General and
Special Rights of the
Mentally Retarded; Oct.
24, 1968
American Psychologist, 18
( I ):56-60, January 1963
24
Organization Code; adoption date Reference
National Association of NASW Code of Ethics;
Social Workers Oct. 13, 1968 <-
2 Park Avenue
New York, N.Y. 10016
U.S. GOVERNMENT PRINTING OFFICE: 1972 O — 445-427
DATE DUE
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